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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000852
Receipt No. R000001023
Scientific Title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Date of disclosure of the study information 2008/06/30
Last modified on 2012/11/29

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Basic information
Public title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Acronym Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Scientific Title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Scientific Title:Acronym Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Region
Japan

Condition
Condition Head and neck squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell and natural killer T (NKT) cell immunotherapy in patients with head and neck squamous cell carcinoma are examined. The clinical effects and immunological responses, safety are also investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Clinical responses
Key secondary outcomes Histopathological decisions of clinical responses, NKT cell specific immunological responses in the tissue and peripheral blood, Frequency of adverse events, Disease free survivals

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed on day 7, and activated NKT cells is infused intra-arterially on day 14 after the entry.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Operable recurrent head and neck squamous cell carcinoma patients who have measurable lesion; Patients whose life-expectancy is more than 6 months; Performance status 0-1; Normal bone marrow, liver and renal functions; NKT cells are detected at least 10 cells in 1 mL of peripheral blood.
Key exclusion criteria Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2137
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigetoshi Horiguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2137
Homepage URL
Email

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 11 Month 29 Day
Date trial data considered complete
2012 Year 11 Month 29 Day
Date analysis concluded
2012 Year 11 Month 29 Day

Other
Other related information

Management information
Registered date
2007 Year 10 Month 16 Day
Last modified on
2012 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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